Status:
TERMINATED
Randomized Trial of Mosapride Versus Placebo in the Treatment of Constipation-Predominant Irritable Bowel Syndrome
Lead Sponsor:
American University of Beirut Medical Center
Conditions:
Constipation-Predominant Irritable Bowel Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether Mosapride, an agent which acts on serotonin receptors in the gastrointestinal tract, is effective in the treatment of constipation-predominant irritab...
Eligibility Criteria
Inclusion
- Rome III Criteria for IBS:
- Patients must have recurrent abdominal pain or discomfort at least 3 days per month during the previous 3 months that is associated with 2 or more of the following:
- Relieved by defecation
- Onset associated with a change in stool frequency
- Onset associated with a change in stool form or appearance
- In addition, patients have to experience at least two of the following symptoms for at least 25% of the time \[11\]:
- Altered stool frequency (\< 3 bowel movements per week)
- Altered stool form (lumpy/hard i.e. Bristol type I-III \[see appendix 1\])
- Altered stool passage (straining, urgency, or a feeling of incomplete evacuation)
- Passage of mucus, bloating, or a feeling of abdominal distension
Exclusion
- Previous allergy to mosapride
- Nocturnal Symptoms (pain in the middle of the night, or other nocturnal symptoms which suggest an organic disease)
- Age \< 18 years
- History of bloody stools or melena
- Diarrhea (\>3 bowel movements per day)
- Constitutional symptoms (fever, weight loss)
- Severe constipation (\< 1 bm/week)
- Pregnancy or lactation
- Patients with history of cardiac arrhythmias
- QT prolongation on baseline ECG
- Chronic laxative use and dependence
- Patients with previous history of congenital heart disease
- Patients with previous history of hypokalemia or hyperkalemia
- Patients taking the following classes of drugs: HIV antivirals, macrolides, anti-arrhythmics, and azole drugs.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00742872
Start Date
September 1 2008
End Date
June 1 2010
Last Update
April 9 2013
Active Locations (1)
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1
American University of Beirut Medical Center
Beirut, Lebanon